Authorised

Product identification

Medicine name:
Dalmaprost 0.075 mg/ml solution for injection for cattle, pigs and horses
Dalmazin Synch 0,075 mg/ml injektionsvæske, opløsning
Active substance:
  • D-CLOPROSTENOL SODIUM SALT
Target species:
  • Cattle (cow)
  • Pig (female)
  • Horse (mare)
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • D-CLOPROSTENOL SODIUM SALT
    0.08
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle (cow)
      • Meat and offal
        no withdrawal period
      • Milk
        no withdrawal period
    • Pig (female)
      • Meat and offal
        1
        day
    • Horse (mare)
      • Meat and offal
        2
        day
      • Milk
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QG02AD90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Available in:
  • Denmark
Package description:
  • box containing 1 HDPE container of 100 ml
  • box containing 1 vial of 20 ml
  • box containing 1 vial of 10 ml
  • box containing 60 vials of 2 ml
  • box containing 15 vials of 2 ml

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Fatro S.p.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Fatro S.p.A.
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 61267
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0305/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 12/04/2023
Download
Danish (PDF)
Published on: 29/06/2023
Download

Package Leaflet

English (PDF)
Published on: 12/04/2023
Download

Labelling

English (PDF)
Published on: 12/04/2023
Download

eu-PUAR-dalmaprost-0.075-mg-ml-solution-for-injection-for-cattle--pigs-and-horses-en.pdf

English (PDF)
Published on: 24/03/2023
Download
Source URL: https://medicines.health.europa.eu/veterinary/600000038882